Sun Pharma, a global specialty generic company based in Mumbai, India, which provides innovative, high-quality, affordable medicines trusted by physicians and patients in more than 100 countries around the world, announced that their novel, pre-mixed, formulation of gemcitabine for intravenous use, is now commercially available in the U.S.
The novel formulation called INFUGEM?, approved by the U.S. Food and Drug Administration (FDA) in July 2018, is the first chemotherapeutic product that comes in a premixed, ready-to-infuse, formulation.
Indication
Gemcitabine is used in combination with other drugs for the treatment of breast cancer (in combination with paclitaxel), ovarian cancer (in combination with carboplatin), non-small cell lung cancer (in combination with cisplatin), and as a first-line, single agent, for the treatment of nonresectable Stage II or Stage III or metastatic (Stage IV) adenocarcinoma of the pancreas in patients previously treated with fluorouracil.
The therapeutic anti-cancer agent is a nucleoside metabolic inhibitor which belongs to the family of drugs called antimetabolites.
Antimetabolites are very similar to normal substances within the cell. When the cells incorporate these substances into the cellular metabolism, they are unable to divide.
Antimetabolites are cell-cycle specific. They attack cells at very specific phases in the cell-cycle.
Novel product
The new formulation is an alcohol-free, clear, colorless, sterile solution of 10mg/mL gemcitabine in 0.9% sodium chloride that is supplied to pharmacists in ready-to-infuse bags as a Spike & Go? package. It involves dose banding practice, whereby standardized doses of intravenous cytotoxic drugs are used for ranges, or ?bands,? of doses calculated for individual patients.
Benefit
Sun Pharma’s gemcitabine formulation does not require reconstitution and syringe withdrawal prior to intravenous administration. Eliminating these steps reduces complexity and minimizes the inherent risks of hazardous drug exposure, contamination, and medication errors.
Use of ready-to-infuse bags eliminates steps in the complex chemotherapy preparation process, reducing exposure and mitigating inherent provider and patient safety risks.
?[This…] is an example of our focus … to improve provider and patient experiences by using high-tech delivery systems and novel formulations for gold-standard medicines,? noted Abhay Gandhi, CEO-North America, Sun Pharma.
?With an increasing number of organizations strongly recommending the use of premixed parenteral products due to concerns related to manual compounding, and with the broad use of gemcitabine to treat various cancers, the timing couldn?t be better [for this] launch [] in the U.S.?
This formulation is the first product using Sun Pharma’s proprietary technology which allows cytotoxic oncology products to be premixed in a sterile environment and supplied to the prescribers in ready-to-infuse final dosage bags. The product is stable at room temperature storage conditions for two years, even without the use of alcohol and other preservatives in the bag. By contrast, other gemcitabine products require reconstitution and/or dilution for patient use, and remain stable at room temperature for only 24 hours.
?The availability of gemcitabine in ready-to-infuse bags is a welcome development, simplifying the complex delivery of this vital chemotherapy medication,? commented Jeff Lombardo PharmD, BCOP, Research Assistant Professor, Center of Integrated Global Biomedical Sciences, University at Buffalo.
Reference
[1] Full Prescribing Information for INFUGEM? [PI]
Last Editorial Review: April 10, 2019
Featured Image: Close up saline IV drip over patient and Infusion pump in hospital. Courtesy:? 2010 ? 2019 Fotolia. Used with permission.
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